A Phase 1b/2 study of KRT-232 in patients with Myelofibrosis

• Research type

  Research Study

• Full title

  An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with Ruxolitinib in Patients with Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post-ET-MF) Who Have a Suboptimal Response to Ruxolitinib

• IRAS ID

  1003066

• Contact name

  Adam Mead

• Contact email

  adam.mead@imm.ox.ac.uk

• Sponsor organisation

  Kartos Therapeutics Inc

• Eudract number

  2019-004554-29

• Research summary

  This is a phase 1b/2 study of KRT-232 combined with ruxolitinib in participants with
  myelofibrosis (MF) who have a suboptimal response after at least 18 weeks of treatment
  with ruxolitinib. This study will test an investigational drug called KRT-232 (also called
  “study drug”) . KRT-232 is a tablet that is taken by mouth with water. Participants will
  take KRT-232 along with another approved drug for myelofibrosis (MF) called
  ruxolitinib. The purpose of this study is to determine an appropriate dose of KRT-232 in
  combination with ruxolitinib for treatment of myelofibrosis (MF). All participants will
  receive KRT-232 combined with ruxolitinib.
  The participant population will consist of male or female individuals age 18 years or
  older with myelofibrosis (MF) (PMF, Post–PV-MF, or Post–ET-MF) who have a
  suboptimal response to ≥18 weeks of treatment with ruxolitinib.
  The total enrollment is expected to be approximately 54 to 78 participants:
  approximately 6 to 18 evaluable participants per arm in Phase 1b, and 21 to 24
  evaluable participants per arm in Phase 2, assuming both Arm 1 and Arm 2 go through
  the Phase 2 expansion phase.
  The study will be conducted at sites which are in a hospital/Clinic.
  The study will be considered complete 2 years after the last participant is enrolled, at
  which time participants who remain on study treatment will be evaluated for eligibility to
  enroll in a rollover study. Or once the participant has finished study there will be no
  provision for the participant to continue on the study medicine. The study doctor will
  discuss their future treatment in accordance with routine standard of care.
  This study is divided into 3 time periods: pre screening, treatment period and a follow up
  period.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  20/SW/0137

• Date of REC Opinion

  15 Oct 2020

• REC opinion

  Further Information Favourable Opinion